FDA label 69fb154f-a494-4f6c-990f-a49ddfc81653

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
5cd41b0a-190d-4460-a536-aa401dc0abb4
SPL ID
69fb154f-a494-4f6c-990f-a49ddfc81653
Version
4
Effective date
2026-09-03
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:46:48

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Clostridium difficile-associated diarrhea (CDAD): A diagnosis of CDAD should be considered for patients taking Proton Pump Inhibitors (PPIs) who develop diarrhea that does not improve. Symptoms include: watery stool abdominal pain fever Patients should seek immediate care from a healthcare professional if these symptoms do not go away while taking this medication. Allergy alert: Do not use if you are allergic to lansoprazole. Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have liver disease had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines digoxin (heart medicine) theophylline (asthma medicine) tacrolimus (immune system medicine) atazanavir (medicine for HIV infection) Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.